Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| PNC15 | PNEUMO (VAXNEUVANCE) | MERCK & CO. INC. | UNK | Z011814 | — |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | 1 | 2142139 | OT |
Caller reported parent refused 2nd dose of ROTATEQ on 1/29/2026. Patient experiencing blood in stool the day after receiving first dose of ROTATEQ. Patient was evaluated in Emergency department and stool found to be positive for rotavirus and ecoli; Patient was evaluated in Emergency department and stool found to be positive for rotavirus and ecoli.; Patient was evaluated in Emergency department and stool found to be positive for rotavirus and ecoli.; This spontaneous report was received from a license practitioner nurse, concerning a 2-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Milk protein intolerance. Concomitant medications included famotidine, Vitamin d, simethicone (GASDROPS). No known drug allergies. On 24-NOV-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) injection 0.5 ml, (lot #Z011814, expiration date: 21-JUL-2027) (route and anatomical location were not reported) as prophylaxis; with first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial 2, (lot #2142139, expiration date: 28-JUN-2026), taken by Oral route as prophylaxis; with Diphtheria vaccine toxoid (+) Hepatitis b vaccine rHBsAg (yeast) (+)Pertussis vaccine acellular 3-component(+)Polio vaccine inact 3v (Vero) (+)Tetanus vaccine toxoid) (PEDIARIX) and HIB vaccine conj (tet tox) (HIBERIX ) (strength, dose, lot number, expiration date, route and anatomical location were not reported) as vaccination. The operator of device was a health professional On 25-NOV-2025 (reported as ''the day after receiving first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ'')), the patient experienced blood in stool. Therefore, she sought medical attention, and she was evaluated in the emergency department and stool found to be positive for rotavirus and E. coli. On unknown date, the patient recovered from the events. On 29-JAN-2026, the parent refused to received 2nd dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ). The causality was not provided. Upon internal review, the event blood in stool was considered to be medically significant.
Milk soy protein intolerance
famotidine; vitamin d; gas drops
Test Date: 20251125; Test Name: stool test; Result Unstructured Data: positive for rotavirus and ecoli.